A Study on the Safety and Effectiveness of Temozolomide for Neoadjuvant Treatment of PPGL

NCT05885386 | Unknown Phase 2

• 1 other identifier: 06086-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the effectiveness oftemozolomide in the neoadjuvant therapy oflocally advanced,or unresectable pheochromocytoma or paragangliom(PPGL). Temozolomide (TMZ) is a novel oral alkylation chemotherapeutic agent. Inthisstudy,temozolomidewill be used preoperatively in order to change unresectable tumors to resectable and reduce the high risk of surgery.

Conditions

Pheochromocytoma; Paraganglioma

Outcome Measures

Primary Outcomes (1)

• The proportion of patients whose tumor change from unresectable to resectable tumor

  The proportion of PPGL patients whose tumor change from unresectable to resectable

  At the end of Cycle 3 (each cycle is 28 days)

Secondary Outcomes (7)

• the objective response rate (ORR)

  At the end of Cycle 3 (each cycle is 28 days)

• The ratio of tumor shrinkage.

  At the end of Cycle 3 (each cycle is 28 days)

• The biochemical response.

  At the end of Cycle 3 (each cycle is 28 days)

• R0 resection rate

  At the end of Cycle 3 (each cycle is 28 days)

• Major pathological response rate (MPR)

  At the end of Cycle 3 (each cycle is 28 days)

Study Arms (1)

Pheochromocytoma or Paraganglioma patients

OTHER

TMZ was administered orally at an initial daily dose of 150 mg/m2 per day for 5 days, every 28 days preoperatively. In patients with a good tolerance during the first cycle, the dose was increased to 200 mg/m2 per day for 5 days, every 28 days.

Drug: Temozolomide

Interventions

Temozolomide DRUG

TMZ was administered orally at an initial daily dose of 150 mg/m2 per day for 5 days, every 28 days preoperatively. In patients with a good tolerance during the first cycle, the dose was increased to 200 mg/m2 per day for 5 days, every 28 days.

Pheochromocytoma or Paraganglioma patients

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• Age 10-70 years old
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
• The patient is diagnosed as pheochromocytoma or paraganglioma which is unresectable with R0 surgery, or extensive and thus maybe requiring resection of important organs, or Inoperable due to heart and other complications, or with very high surgical risk.
• Estimated life expectancy longer than 6 months.
• Confirmed non-pregnancy and lactation. During the entire study period and within 6 months after the last administration, the subjects and their spouses are willing to use efficient contraceptive measures.
• Laboratory requirements:
• Absolute granulocyte count (AGC) greater than 1.5 x 109/L;
• Platelet count greater than 80 x 109/L; 3) Hemoglobin greater than 90g/L;
• Serum bilirubin less than 1.5 x upper limit of normal (ULN);
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN; Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min;
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).

You may not qualify if:

• Have other tumors.
• Patients were treated with other antitumor agents.
• Pregnant or nursing women.
• A history of allergic reactions to temozolomide or dacarbazine.
• Severe myelosuppression or abnormal coagulation.
• Severe liver and kidney insufficiency.
• Bowel obstruction or other conditions that interfere with taking medication.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anli Tong

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anli Tong

CONTACT

13911413589; tonganli@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PPGLs could not be performed R0 resection due to the large tumor size and close relationship with surrounding tissues (blood vessels, kidneys, pancreas, liver, etc.)

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)